A reaction mixture containing the following components;A. Tetralithium [2(or 3), 9 (or 10), 16 (or 17), 23 (or 24)-tetrakis (3-sulfonato-propylsulfonyl) phthalocyaninato]cupurate (II)B. Trilithium [3-(2-hydroxylpropylsulfamoyl)propylsulfonyl]tris (3-sulfonato-propylsulfonyl)phthalocyaninatocupurate (II)C.Dilithium bis [3-(2-hydroxylpropylsulfamoyl)propylsulfonyl] bis (3-sulfonato-propylsulfonyl)phthalocyaninatocupurate (II)D. Lithium tris [3-(2-hydroxylpropylsulfamoyl)propylsulfonyl] (3-sulfonato-propylsulfonyl)phthalocyaninatocupurate (II)E. Tetrakis [3-(2-hydroxpropylsulfamoyl) proppylsulfonyl]phthalocyaninatocupurate (II)In the ratio A:B:C:D:E 6.25 : 25 : 37.5 : 25 : 6.25

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Testing was conducted between 04 March 2005 and 30 March 2005. Final report was issued 13 June 2005.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Meets the criteria for classification as reliable without restriction according to Klimisch et al (1997).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)

Deviations:

no

GLP compliance:

yes

Type of method:

cascade impaction

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Results and discussion

Particle size

Key result

Percentile:

other: proportion of test material with particle size < 100 um

Remarks on result:

other: 71% of test material is < 100 um

Particle size distribution at different passages

Particle size distribution at different passages 1

No.:

#1

Size:

< 100 µm

Distribution:

ca. 71 %

Particle size distribution at different passages 2

No.:

#2

Size:

< 10.2 µm

Distribution:

ca. 4.52 %

Particle size distribution at different passages 3

No.:

#3

Size:

< 5.4 µm

Distribution:

ca. 1.35 %

Applicant's summary and conclusion

Conclusions:

The proportion of test material having a particle size less than 100 um was determioend to be 71%

Executive summary:

Introduction

The method used is designed to comply with that given in 'Particle Size Distribution, Fibre Length and Diameter Distribution', June 1996 European Commission technical guidance document, which satisfies the requirements of OECD Guideline 1 10.

Results and conclusions

Particle size data acquired for the test material are shown in the following table:

Measurement  Method  Result  Proportion of test material having an inhalable particle size les than 100µm  sieve  71%  Proportion of test material having a thoracic particle size less than 10.2µm  Cascade Impactor  4.52%  Proportion of test material having a respirable particle size less than 5.4µm  Cascade Impactor  1.35%